Kidney disease

Kidney Foundation Marks 60th Anniversary

Retrieved on: 
Thursday, February 29, 2024

Learn more during Kidney Health Month in March

Key Points: 
  • Montreal, Quebec--(Newsfile Corp. - February 29, 2024) - When the Kidney Foundation of Canada was launched in 1964, a person with kidney failure had very little hope of survival.
  • As we work to raise awareness of these vital organs, The Kidney Foundation is reflecting on the significant progress made in the past six decades to improve the quality of life and health outcomes of kidney patients.
  • "These advances are providing new hope for people diagnosed with kidney disease and those living with kidney failure."
  • The Kidney Foundation is ramping up advocacy efforts to ensure that every Canadian has access to the care they need to prevent or delay the progression of kidney disease.

Travere Therapeutics Submits Supplemental New Drug Application to the U.S. Food and Drug Administration Seeking Full Approval of FILSPARI® (sparsentan) for the Treatment of IgA Nephropathy (IgAN)

Retrieved on: 
Monday, March 11, 2024

The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.

Key Points: 
  • The sNDA is based on 2-year confirmatory results from the Phase 3 PROTECT Study, the only head-to-head study in IgAN versus an active comparator.
  • “Since being introduced under accelerated approval, FILSPARI has positively impacted the lives of many people living with IgAN.
  • “FILSPARI is at the forefront of emerging new treatment options providing hope for a delay in kidney transplant or dialysis.
  • The FDA has 60 days from the receipt of the application to determine whether to accept it for review.

Multi-Center Study Presented by Duke at Heart Failure Therapeutics Conference Highlights Daxor’s Unique Clinical Utility for Heart Failure Patients

Retrieved on: 
Friday, March 8, 2024

Oak Ridge, TN, March 08, 2024 (GLOBE NEWSWIRE) -- Daxor Corporation (Nasdaq: DXR), the global leader in blood volume measurement technology, today announces new data from Duke University Medical Center validating the benefits of blood volume analysis (BVA) in optimizing individualized therapy for heart failure patients with impaired renal function. Data were presented on 259 patients from three centers at the Technology and Heart Failure Therapeutics Conference (THT), which brought together the world’s leading experts in heart failure innovations at the Westin Boston Seaport in Boston, Massachusetts March 4-6, 2024.

Key Points: 
  • Data were presented on 259 patients from three centers at the Technology and Heart Failure Therapeutics Conference (THT), which brought together the world’s leading experts in heart failure innovations at the Westin Boston Seaport in Boston, Massachusetts March 4-6, 2024.
  • The study, titled, ‘Blood Volume Profiles and Correlations with Pressures in Heart Failure with Impaired Renal Function,’ aimed to answer if the degree of renal impairment in heart failure patients impacts volume status, the pressure-volume relationship, and the prevalence and types of anemia.
  • Veraprapas Kittipibul M.D., lead investigator of the study concluded that:
    Heterogeneity in volume exists across renal function which can only be accurately measured with BVA.
  • Patients with large volume expansion had worsening renal function, showing the urgent need for care.

Unicycive Therapeutics Completes Enrollment in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC)

Retrieved on: 
Thursday, March 7, 2024

LOS ALTOS, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced enrollment has been completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).

Key Points: 
  • LOS ALTOS, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced enrollment has been completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).
  • OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
  • “The completion of enrollment in our pivotal OLC clinical trial is a critical achievement for Unicycive as we strive to bring an improved therapy to chronic kidney disease patients struggling with hyperphosphatemia,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive.
  • “Positive results from the trial will provide the basis to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA).

Arch Biopartners Announces Dosing of First Patient in Phase II Trial for LSALT Peptide Targeting Cardiac Surgery Associated-Acute Kidney Injury

Retrieved on: 
Thursday, March 7, 2024

TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).

Key Points: 
  • TORONTO, March 07, 2024 (GLOBE NEWSWIRE) -- Arch Biopartners Inc. , (“Arch” or the “Company”) (TSX Venture: ARCH and OTCQB: ACHFF), announced today that patient recruitment and dosing has begun in Turkey for the Phase II trial for LSALT peptide targeting the prevention and treatment of cardiac surgery-associated acute kidney injury (CS-AKI).
  • LSALT peptide is the Company’s lead drug candidate for preventing and treating inflammation injury in the kidneys, lungs and liver.
  • The Arch Biopartners team is currently working with hospital sites in Canada to prepare for their participation in this Phase II trial.
  • The CS-AKI Phase II trial is an international multi-center, randomized, double-blind, placebo-controlled study of LSALT peptide.

Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 by the U.S. Food and Drug Administration for the Prevention of Delayed Graft Function in Kidney Transplant Patients

Retrieved on: 
Monday, March 4, 2024

LOS ALTOS, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.

Key Points: 
  • LOS ALTOS, Calif., March 04, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced that the U.S. Food and Drug Administration has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.
  • UNI-494 is a cytoprotective agent that elicits an ischemic preconditioning effect by activating KATP channels in mitochondria to restore mitochondrial function.
  • “We are pleased to announce that the FDA has granted orphan drug designation to UNI-494 for the prevention of delayed graft function after kidney transplantation, an unmet medical need for which there are no FDA-approved drugs,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive.
  • “Obtaining ODD is an important milestone in the development of UNI-494 that may provide certain tax credits for qualified clinical trials, exemption of user fees, and the potential for seven years of market exclusivity after approval.

Kidney Month: 31 Day of Action to Equip and Empower People to Fight Kidney Disease

Retrieved on: 
Thursday, February 29, 2024

During Kidney Month, AKF calls on members of the kidney community and the general public to join in solidarity in support of everyone affected by kidney disease.

Key Points: 
  • During Kidney Month, AKF calls on members of the kidney community and the general public to join in solidarity in support of everyone affected by kidney disease.
  • One of the hallmarks of Kidney Month at AKF is Kidney Action Week , which will be held March 18-22.
  • This free, virtual event will bring together patients, nephrologists, renal dieticians, caregivers and other kidney experts for a weeklong series of sessions about a variety of topics related to kidney disease, including dialysis, kidney disease prevention, kidney-friendly eating, transplant, innovations in kidney disease and more.
  • In addition, people with kidney disease have a higher chance of developing other health problems, such as heart disease.

Hippocratic AI Partners with Leading Health Systems, Digital Health Companies to Evaluate World's First Generative AI Powered Healthcare Provider

Retrieved on: 
Thursday, February 29, 2024

“Generative AI holds huge potential for improving healthcare access, equity, and outcomes but its impact has thus far been limited to back-office applications.

Key Points: 
  • “Generative AI holds huge potential for improving healthcare access, equity, and outcomes but its impact has thus far been limited to back-office applications.
  • At Hippocratic AI, we believe that the industry can—and should—aim higher,” said Munjal Shah, co-founder and CEO of Hippocratic AI.
  • Together with its partners, Hippocratic AI will continue to add conditions as well as develop additional products and workflows over time.
  • We’re excited to partner with Hippocratic AI to conduct internal testing to ensure the safety and efficacy of the AI tools they’re building.”

Travere Therapeutics and CSL Vifor Announce Sparsentan Receives Positive CHMP Opinion for the Treatment of IgA Nephropathy

Retrieved on: 
Friday, February 23, 2024

SAN DIEGO, Feb. 23, 2024 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc., (NASDAQ: TVTX) and CSL Vifor today announced that the European Medicines Agency’s (EMA) CHMP has recommended approval of sparsentan for the treatment of adults with primary IgA nephropathy (IgAN) with a urine protein excretion >1.0 g/day (or urine protein-to-creatinine ratio ≥0.75 g/g). IgAN is a rare kidney disease and a leading cause of kidney failure. The CHMP opinion provides the basis for the European Commission’s final decision regarding CMA for sparsentan. If approved in Europe, sparsentan will be the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist for the treatment of IgAN.

Key Points: 
  • The CHMP opinion provides the basis for the European Commission’s final decision regarding CMA for sparsentan.
  • If approved in Europe, sparsentan will be the first non-immunosuppressive, single-molecule, dual endothelin angiotensin receptor antagonist for the treatment of IgAN.
  • In August 2022, Travere Therapeutics and CSL Vifor announced they had submitted a Marketing Authorization Application (MAA) for CMA to the EMA.
  • In 2021, Travere Therapeutics granted CSL Vifor exclusive commercialization rights for sparsentan in Europe, Australia and New Zealand.

Where You Live Impacts Your Ability to Save a Life Through Living Organ Donation, According to the 2024 American Kidney Fund Report Card

Retrieved on: 
Thursday, February 22, 2024

Receiving a kidney from a living donor is the best option for someone in need of a new kidney.

Key Points: 
  • Receiving a kidney from a living donor is the best option for someone in need of a new kidney.
  • However, six states – Alabama, Montana, New Hampshire, Tennessee, South Dakota and Vermont – have zero policy protections (F grade) for living organ donors.
  • How All 50 States + DC Fared on the 2024 State of the States: American Kidney Fund Report Card
    Currently, chronic kidney disease (CKD) affects more than 1 in 7 adults in the U.S.
  • “Where you live should not impact whether you are able to save a life through kidney donation, but our 2024 Report Card suggests that this may be the case.